Yoga for Patients With Rheumatoid Arthritis

NCT ID: NCT03500276

Last Updated: 2020-05-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

57 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-04

Study Completion Date

2020-04-01

Brief Summary

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The purpose of this study is to investigate the effects of a yoga program based on "Yoga in daily life system" in patients with rheumatoid arthritis.

The investigators want to explore whether this program will improve health-related quality of life and psychological well-being in patients. In addition they want to explore its potential positive modulation of the immune system.

Detailed Description

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Rheumatoid arthritis (RA) is a chronic disabling inflammatory disease that substantially impacts health-related quality of life (HRQOL) of patients. In addition to pain, fatigue and physical disability the disease also affects psychological health. Yoga, a mind-body therapy, integrates physical exercises with relaxation and meditation. Published data suggest its beneficial effects on both physical and mental health in various chronic conditions. The true biological mechanism underlying these effects is not well known. Recent research suggests potential modulation of the immune system and inflammation-related gene expression changes.

Hypothesis: Yoga program based on Yoga in daily life system has positive impact on clinical and biologic outcomes in RA patients.

Aims: To determine the impact of a 12-week yoga program on measures of psychological distress, HRQOL, fatigue, pain, disease activity, levels of circulating inflammatory markers and pro-inflammatory gene expression.

Materials and methods: 50 RA patients, aged 18-65 years, on stable standard pharmacological treatment will be randomly assigned to a 12-week yoga intervention (based on "Yoga in daily life system") or arthritis-education control. Self-administered questionnaires will be used to assess quality of life and psychological well-being of the patients. Blood samples will be collected for measurement of inflammatory markers and expression of a set of pro-inflammatory genes. Disease activity will be assessed by DAS28CRP score. The patients will be assessed on baseline, post-treatment and at 3 months follow-up.

This research will provide information on potential efficacy of yoga program in improving physical and psychological outcomes in persons with RA and explore its influence on immunological system.

Conditions

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Rheumatoid Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized controlled clinical trial
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors
Blinded rater will be used to assess disease activity by DAS28CRP score.

Study Groups

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Yoga program

12 weeks of "Yoga in daily life practice", 2x weekly for 90 minutes including physical exercises (asanas), breathing exercises (pranayama), relaxation and meditation exercises.

Group Type EXPERIMENTAL

Yoga program

Intervention Type BEHAVIORAL

Yoga classes will be conducted 2xweekly/ 90 minutes and consist of physical exercises (asanas), breathing exercises (pranayama), relaxation and self-enquiry meditation based on Yoga in daily life system.

Arthritis-education control

12 weeks of arthritis - education classes, consisting of 1x weekly sessions for 120 minutes including lectures on arthritis and related issues followed by group discussion.

Group Type ACTIVE_COMPARATOR

Arthritis-education

Intervention Type BEHAVIORAL

Arthritis-education classes will be conducted 1xweekly/ 120 minutes and led by rheumatology specialists and consist of lectures on arthritis and related issues followed by group discussion.

Interventions

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Yoga program

Yoga classes will be conducted 2xweekly/ 90 minutes and consist of physical exercises (asanas), breathing exercises (pranayama), relaxation and self-enquiry meditation based on Yoga in daily life system.

Intervention Type BEHAVIORAL

Arthritis-education

Arthritis-education classes will be conducted 1xweekly/ 120 minutes and led by rheumatology specialists and consist of lectures on arthritis and related issues followed by group discussion.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

1. ACR/EULAR 2010. classification criteria for rheumatoid arthritis (RA)
2. disease activity measured by DAS28CRP\< 5.1
3. patients on stable dose of disease-modifying antirheumatic medications,non-steroidal anti-inflammatory drugs or low-dose glucocorticoids for the last 3 months

Exclusion Criteria

1. significant co-morbidity (active malignant disease, symptomatic ischemic heart disease or heart failure, severe lung disease, uncontrolled thyroid disease, neurological disease that impairs mobility) that is more limiting than RA
2. history of drug or alcohol abuse
3. recent injury/ or surgery
4. regular practice of yoga or similar technique in the last 6 months or currently engaged in a structured exercise program for \>=2 times weekly, patients that are currently engaged in physical therapy
5. pregnant or planning pregnancy
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital Dubrava

OTHER

Sponsor Role lead

Responsible Party

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SILVA PUKŠIĆ

MD, PhD candidate

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Silva Pukšić, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Dubrava

Jadranka Morović-Vergles, MD, PhD

Role: STUDY_CHAIR

University Hospital Dubrava

Locations

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University Hospital Dubrava

Zagreb, , Croatia

Site Status

Countries

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Croatia

Other Identifiers

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DUBRAVA-YOGRA-01

Identifier Type: -

Identifier Source: org_study_id

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